The VLIFT system utilizes a distractible in-situ (DIS) implant which enables the surgeon to adjust the height of the cage to suit the anatomy of the patient. The pre-assembled VLIFT cage adjusts easily with a low profile inside thread design. The cage also includes a pre-assembled locking screw which can be engaged after distraction to lock the mechanism in place. Cage extensions snap into place on each end to build a longer implant construct. For example, an 18mm cage in width that is 60mm in length can be extended to 75mm in length with an extension at one end and up to 90mm in length when using two extensions. Modular end-caps snap into each end for quick assembly. The exterior side of the end-caps feature evenly spaced metal spikes, providing fixation to the bony endplates of adjacent vertebral bodies. The use of bone graft with VLIFT is optional.VLIFT is a vertebral body replacement system intended to replace a vertebral body or an entire vertebra in the thoracolumbar spine (T1-L5). For both corpectomy and vertebrectomy precoedures, the VLIFT system is intended to be used with supplemental internal fixation systems (Xia, Spiral Radius 90D, or Trio+).
Features and Benefits:
Key advantages include:
Single, pre-assembly cage
Large windows for in-situ insertion of bone graft into cage Cage diameters: 18mm and 22mm
Cage lengths 16mm-70mm, 25mm-70mm
Cage and end caps made of titanium alloy
Cage extensions: 18mm, 22mm diameter x 15mm long
Modular end caps with large surface area for load bearing to prevent subsidence and aid stabilization of affected motions segement(s)
End caps: flat angle or with inclines (0, 3 or 8 degree) match lordsis of spinal segment
Open end caps to maximize bone-to-bone graft contact
Lordotic options to build a 0, 3, 6, 8, 11, or 16 degree construct
Single surgical instrument for simple insertion and distraction
Titanium alloy for mechanical integrity during impaction/distraction, X-ray visibility, MRI compatibility, biocompatibility
Implant and instrument ideal for anterior/antero-lateral approaches
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( 3 / 136 )• Superior primary stability in the early days of recovery post-op.
• Superior continued stability during the period of healing (the period of erosive creeping substitution).
• Long term stability in the period of bony fusion with annealing the risk of subsidience.
• Permanent possibility of excellent monitoring of the healing parameters and/or eventual failures.
• Possibility to use bone inducting ingredients.
• Available in all possible anatomic dimensions - straight or lorgatic.
• Isodense bony bridging
• Safety assessment and proven effectiveness.
• Ease of use, ease of instrumentation.
• Possibility to lordose.
• Possibility to use stand alone procedure.
• No NMR interference.
• In use since March '95 with more than 10.000 cases worldwide.
• Over 12 years of follow-up.
• Presented in national and international well respected congresses.
• Assessed Quality Managment CE marked.
• Supported and documented by litterature of international accepted professional level
Cervical Titanium Peek Anterior Corpus Replacement Cage
• Enhanced primary stability of postoperative site.
• Easy handling and simplicity of its instrumentation.
• Titanium tracers for RX visualisation.
• Most adequate decompression of spinal cord and/or nerve roots.
• Very large choice of implant configurations to meet patients anatomy.
• Proven effectiveness follow-up study.
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( 3 / 144 )Invadur® CWKK System (Cervical vertebral body replacement - Stackable combination system) - Overview of the Implants (Invadur® Vertebral replacement 12.14 - Invadur® Comb.-Adapter 12.14 - Invadur® Vertebral replacement 14.16 - Invadur® Comb.-Adapter 14.16).
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The ADD (anterior distraction device) implant is a distractable vertebral body replacement for the anterior cervical and thoracic spine. The is used for reconstruction of bone mass defects and the spinal profile as well as for support and stabilization of the anterior spinal column. Additional ventral or dorsal stabilization is necessary.
ADDplus(anterior distraction device plus) is likewise a vertebral body replacement used in the reconstruction, support and stabilization of the anterior cervical spine and the cervico-thoracic transition. ADDplus resulted from the rigorous ongoing optimization of our ADD and osmium systems. This direct combination of vertebral body replacement and ventral plating unites two systems. Fixation on the vertebral bodies is achieved using osmium (hyperlink) screws. Both monocortical and bicortical screw anchorage can be used.
Both implants are used to correct instability of various origins, resulting from tumors or fractures, for instance. They are continuously distractable in situ, so that precise bridging of the defect is ensured.
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( 3 / 117 )DSS for Dynamic Soft Stabilization. It’s similar to Dynesys in that it uses pedicle screws with a flexible spacer, but with many improvements. Dynesys spacers are of fixed length. Along with the very wide screw head spacing and the tight cord, this results in a somewhat rigid system with almost no motion in lateral bending. It accomplishes the design goals of allowing some continued motion while providing stabilization, but it does it in a way that does not allow anything close to the normal kinematics of the implanted levels. Because of this, the screw loading remains high and the stiff system can still transmit additional load to the adjacent segments.
The design goals for DSS included allowing more natural kinematics, but only in a neutral or ‘safe’ zone. For most of us, pain is generated when we weight the disc, or when we overload portions of the system by venturing into more extreme ranges of motion. (Bending, lifting, twisting.) If natural kinematics are maintained, but motion is maintained with the neutral zone, the system stays in the ‘safe’ range.
The DSS system is a modular design that includes the ‘soft’ module that provides flexibility not only in flexion and extension, but also in lateral bending. Allowing expansion in flexion and compression in extension, compound movements and lateral bending produces more normal kinematics than does Dynesys. This ‘softer’ system should provide reduced loading on adjacent segments compared to Dynesys and also reduced loading on the screws.
One of the most important features of DSS is the modular design. In addition to the flexible spacers, the DSS system includes rigid spacers for traditional fusion. With this modular system, multi-level procedures can easily mix fusion and soft stabilization. More importantly, if the soft stabilization must ultimately be revised to fusion, a small procedure to remove the flexible spacers and replace them with rigid ones will be all that is necessary. The screws… the other levels can all be left alone… just replace the appropriate segments. The easy revision promised for Dynesys is great in theory… not in practice.
Paradigm Spine, LLC, a developer of innovative non-fusion spinal implant solutions, announced that it has received a European Union CE Mark for its DSSTM implantable dynamic spine stabilization system. The CE Mark will allow the company to begin marketing the DSSTM system in Europe and many other countries that recognize the certification.
The first surgery involving the DSSTM system was performed on April 27th, 2007 in Straubing, Germany by Dr. Rudolf Bertagnoli.
The DSSTM system is a pedicle-screw based, implantable dynamic spine stabilization system indicated for degenerative disc disease (DDD) of the lumbar spine. The DSSTM system incorporates a hybrid philosophy, combining elements of fusion and motion preservation.
The system was developed over a two-year period in close cooperation with Professor Hans- Joachim Wilke, a world-renowned Professor of Biomechanics from the University of Ulm in Germany, and Dr. Bertagnoli, the most experienced spine arthroplasty surgeon worldwide.
The modularity of the DSSTM system enables the combination of DSS dynamic couplers with DSS fusion couplers at adjacent levels. Therefore, one segment may have functionally dynamic stabilization (non-fusion) while an adjacent segment has rigid segmental fixation (fusion) under the same system.
The DSS dynamic coupler increases the stiffness of the affected motion segment and restricts the range of motion in flexion, extension, lateral bending and rotation while preserving motion. By selecting the appropriate size DSS dynamic coupler, the posterior segmental height can also be adjusted. The DSS fusion coupler provides rigid segmental fixation utilizing the same instrument set. One of the features and benefits of the system is the use of percutaneous screw
positioning that facilitates a minimally invasive muscle-sparing approach.
Marc R. Viscogliosi, Chief Executive Officer of Paradigm Spine, said, “The DSSTM system is the product of collaborative thinking between two of the world’s most experienced spine motion- preserving experts, from both a scientific and clinical point-of-view.”
“The DSSTM system is one of the first truly dynamic stabilization systems because it increases segmental stiffness while controlling specific ranges of motion as the patient goes about his or her daily activities,” he noted. “We are particularly excited to have benefited from the enthusiastic development efforts and significant contributions of Professor Wilke and Dr. Bertagnoli.”
Professor Wilke said, “I worked very closely with the Company on incorporating the key strategic and scientific elements of the ranges and types of motion which need to be controlled by a true dynamic stabilization system. Specifically, we designed the system to focus on controlling ‘active zone’ motions, which are normally associated with pathologic painful arcs of motion.”
Professor Wilke further added, “This product reflects what we have learned about the function of the human spine from multiple spine experiments over many years, based on studies conducted with our validated Finite Element model of a lumbar spinal segment.”
Dr. Bertagnoli said, “The surgery on Friday [April 27] went very well and I believe the DSSTM system has the potential to become an important new option in the continuum of spine care.
Having used most of the major spine arthroplasty products I, like Professor Wilke, am convinced of the uniqueness and potential impact of the DSSTM system for the treatment of my patients.”
The DSSTM system is Paradigm Spine’s fourth product to receive a CE Mark, following the coflex® interspinous implant, the DCITM dynamic cervical implant, which received the CE Mark on December 5, 2006; and the coflex-FTM implant system which received the CE Mark on December 15, 2006.
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